This invention relates to a method and apparatus for the delivery, or placement, of, for example, a voice prosthesis device into a puncture provided in the tracheoesophageal wall of a speech restoration patient.
A speech restoration technique is known wherein air from the trachea is diverted from its normal flow path out through the tracheostoma to a flow path through a voice prosthesis providing a more or less permanent passageway to the esophagus. Esophageal speech results. See U.S. Pat. Nos. 4,435,853; 4,614,516; and 4,911,716. Voice prostheses currently in use for providing controlled air pathways through tracheoesophageal punctures incorporate flexible retention collars. The retention collar lies against the esophageal surface of the tracheoesophageal wall to reduce the likelihood of dislodgement of the prosthesis from the puncture. While this configuration substantially improves retention, the presence of the large retention collar makes insertion of a prosthesis more difficult and traumatic to the tissue surrounding the tracheoesophageal puncture. A possibility inherent in difficult or traumatic prosthesis insertion is incomplete insertion. Incomplete insertion may result in aspiration of the prosthesis into the airway. The prosthesis may be expelled by coughing, requiring endoscopic retrieval from the airway. Additionally, concern about prosthesis insertion difficulty may prevent some patients and physicians from employing this method of voice restoration.
According to an aspect of the invention, a device is provided for insertion into a first opening in a human body. The device includes a device body having a longitudinal axis and a flexible first flange provided on an outside surface of the device body. The first flange has a deployed, use orientation in which it projects generally outwardly from the outside surface of the device body and an undeployed, insertion orientation in which it is resiliently deflected toward the device body. A retainer retains the flange in its insertion orientation. The retainer is constructed of a material soluble in a fluid.
According to another aspect of the invention, a method is provided for inserting into a first opening in a human body a device including a device body having a longitudinal axis and a flexible first flange provided on an outside surface of the device body. The first flange has a deployed, use orientation in which it projects generally outwardly from the outside surface of the device body. The method comprises the steps of resiliently deflecting the flange toward the device body, placing over the resiliently deflected flange a retainer of a material soluble in a fluid, and inserting the device into the first opening.
Illustratively according to these aspects, the invention includes means for, or the step of, introducing the fluid into contact with the retainer.
Further illustratively according to these aspects, the first flange is positioned adjacent a first end of the device body which is inserted into the first opening.
Additionally, illustratively according to these aspects, a second flange is spaced along the device body from the first flange toward a second end of the device body.
Illustratively, the second flange is a flexible flange.
Further, illustratively according to these aspects, the invention includes an instrument for, or the step of, deflecting the flange to its insertion orientation to aid in placing the retainer around the deflected flange. The instrument has a second opening having a cross section slightly larger than a cross section of the device body transverse to its longitudinal axis.
Illustratively according to these aspects of the invention, the first opening is a first opening in a wall having a first side and a second side. The method further comprises the step of pushing the device body, resiliently deflected flange first, from the first side into the first opening so that the resiliently deflected flange lies on the second side of the wall.
Alternatively according to these aspects of the invention, the method comprises the step of pulling the device body, resiliently deflected flange first, from the second side into the first opening so that the resiliently deflected flange lies on the first side of the wall.
According to another aspect of the invention, a device for insertion into an opening in a human body includes a resiliently deflectable device body. The body has an insertion cross section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent. A retainer retains the device body in its insertion cross section. The retainer is removable to permit deployment of the device body to its use cross section.
According to yet another aspect of the invention, a method is provided for inserting into an opening in a human body a device. The device includes a resiliently deflectable device body having an insertion cross-section transverse to its longitudinal extent which is insufficient to fill the opening and a larger use cross section transverse to its longitudinal extent. The method comprises the steps of resiliently deflecting the device body, placing over the resiliently deflected device body a retainer for retaining the device body in its insertion cross section, inserting the device with the retainer in place into the opening, and removing the retainer to permit deployment of the device body to its use cross section.
Illustratively according to these latter aspects of the invention, the retainer is soluble in a fluid.
Additionally illustratively according to these aspects, the invention further comprises means for, or the step of, introducing the fluid into contact with the retainer.
The term xe2x80x9ccylindrical bodyxe2x80x9d, as used herein, means a body including a surface generated by a straight line parallel to another straight line moving in a closed path.